Medical and Physiological Benefits and Mechanisms of Reduced Sitting Without Meeting the Current Physical Activity Recommendations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- The change in whole-body insulin sensitivity
研究概览
简要总结
The most important objective of this randomized controlled trial in subjects with increased cardiovascular and metabolic risk factors is to investigate whether only reduced daily sitting improves human cardiovascular and metabolic health during a six-month intervention. It is hypothesized and expected that only reduced sitting, without formal physical activity or exercise training, affects favorably cardiovascular and metabolic health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention, masking of the participants is not possible. Analyzing of the obtained data will be masked.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Physically inactive (less than 120 minutes of moderate intensity exercise per week measured by the activity monitor during run-in)
- •Sitting time ≥ 10 h /day (measured by the activity monitor during run-in)
- •BMI 25-40
- •Blood pressure < 160/100 mmHg
- •Fasting plasma glucose < 7.0 mmol/l
- •Fulfills the criteria of the metabolic syndrome according to Alberti et al 2009
排除标准
- •History of a cardiac event
- •Insulin or medically treated diabetes
- •Any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
- •Presence of ferromagnetic objects that would make MR imaging contraindicated
- •Abundant use of alcohol
- •Use of narcotics
- •Smoking of tobacco or consuming snuff tobacco
- •Diagnosed depressive or bipolar disorder
- •Previous PET imaging or considerable exposure to radiation
结局指标
主要结局
The change in whole-body insulin sensitivity
时间窗: The change from baseline to 6 months
M-value during the hyperinsulinemic euglycemic clamp
The change in skeletal muscle insulin-stimulated glucose uptake
时间窗: The change from baseline to 6 months
Glucose uptake in the femoral muscles will be measured by positron emission tomography (PET) with \[18F\]-labelled fluoro-deoxy-glucose (FDG) tracer during hyperinsulinemic euglycemic clamp
次要结局
- The change in maximal oxygen uptake(The change from baseline to 6 months)
- The change in plasma glucose(The change from baseline to 6 months)
- daily hours spent physically active(through study completion, an average of 6 months)
- The change in liver adiposity(The change from baseline to 6 months)
- The change in body fat percentage(The change from baseline to 6 months)
- The change in HbA1c(The change from baseline to 6 months)
- daily sitting hours(through study completion, an average of 6 months)
研究者
Ilkka Heinonen
Principal Investigator
University of Turku